South cluster Manager

Posted 09 Mar 2020

Montevideo - all, Montevideo - Uruguay

Req Id 204039

Details

Oversee and coordinate day-to-day operations for country cluster

Responsibilities                                                                                                        

  • Lead, build and manage a professional team in Regulatory Affairs department for the products & countries under his/her responsibility.
  • Coaches & directs team to produce excellent work; provides development opportunities for team to reach their full potential.
  • Develop regulatory product plans based on global/regional/local business strategy
  • Ensure plan alignment cross functionally
  • Provide regulatory support and insights for country/ commercial strategies and initiatives
  • Plan, manage, review & finalize submission with follow up until final approval
  • Provide support for specific local M1 requirements (including NPIs, Artworks, mock- ups, Samples etc...) & manage country input and fees planning
  • Communicate with partners & key local stakeholder functions including agents
  • Plan, prepare & conduct local HA interactions
  • Maintain close communication & alignment with HA & other agencies as applicable
  • Represent Merck & prepare communication to industry as applicable
  • Enable documentation & communication of reg. intelligence
  • Cross-functionally coordinate crisis management such as stock-outs and maintain HA interaction
  • Review and approve promotional material
  • Provide relevant support for clinical trials as applicable

 

Education & Experience: 

  • University degree (Master, PhD) in pharmaceutical science or an equivalent qualification with relevant work experiences
  • at least 5+ years of experience in the regulatory affairs field (local RA proficiency) and in positioning leading high-performance teams.
  • Demonstrated ability of communication and collaboration with internal and external stakeholders
  • High proficiency in English and local languages is a must, as applicable.
  • Travel flexibility.
  • Financial proficiency is a plus.

 

 

#TeamMerck #NotintendedforUSorCAvisitors


Oversee and coordinate day-to-day operations for country cluster

Responsibilities                                                                                                        

  • Lead, build and manage a professional team in Regulatory Affairs department for the products & countries under his/her responsibility.
  • Coaches & directs team to produce excellent work; provides development opportunities for team to reach their full potential.
  • Develop regulatory product plans based on global/regional/local business strategy
  • Ensure plan alignment cross functionally
  • Provide regulatory support and insights for country/ commercial strategies and initiatives
  • Plan, manage, review & finalize submission with follow up until final approval
  • Provide support for specific local M1 requirements (including NPIs, Artworks, mock- ups, Samples etc...) & manage country input and fees planning
  • Communicate with partners & key local stakeholder functions including agents
  • Plan, prepare & conduct local HA interactions
  • Maintain close communication & alignment with HA & other agencies as applicable
  • Represent Merck & prepare communication to industry as applicable
  • Enable documentation & communication of reg. intelligence
  • Cross-functionally coordinate crisis management such as stock-outs and maintain HA interaction
  • Review and approve promotional material
  • Provide relevant support for clinical trials as applicable

 

Education & Experience: 

  • University degree (Master, PhD) in pharmaceutical science or an equivalent qualification with relevant work experiences
  • at least 5+ years of experience in the regulatory affairs field (local RA proficiency) and in positioning leading high-performance teams.
  • Demonstrated ability of communication and collaboration with internal and external stakeholders
  • High proficiency in English and local languages is a must, as applicable.
  • Travel flexibility.
  • Financial proficiency is a plus.

 

 

#TeamMerck #NotintendedforUSorCAvisitors


Oversee and coordinate day-to-day operations for country cluster

Responsibilities                                                                                                        

  • Lead, build and manage a professional team in Regulatory Affairs department for the products & countries under his/her responsibility.
  • Coaches & directs team to produce excellent work; provides development opportunities for team to reach their full potential.
  • Develop regulatory product plans based on global/regional/local business strategy
  • Ensure plan alignment cross functionally
  • Provide regulatory support and insights for country/ commercial strategies and initiatives
  • Plan, manage, review & finalize submission with follow up until final approval
  • Provide support for specific local M1 requirements (including NPIs, Artworks, mock- ups, Samples etc...) & manage country input and fees planning
  • Communicate with partners & key local stakeholder functions including agents
  • Plan, prepare & conduct local HA interactions
  • Maintain close communication & alignment with HA & other agencies as applicable
  • Represent Merck & prepare communication to industry as applicable
  • Enable documentation & communication of reg. intelligence
  • Cross-functionally coordinate crisis management such as stock-outs and maintain HA interaction
  • Review and approve promotional material
  • Provide relevant support for clinical trials as applicable

 

Education & Experience: 

  • University degree (Master, PhD) in pharmaceutical science or an equivalent qualification with relevant work experiences
  • at least 5+ years of experience in the regulatory affairs field (local RA proficiency) and in positioning leading high-performance teams.
  • Demonstrated ability of communication and collaboration with internal and external stakeholders
  • High proficiency in English and local languages is a must, as applicable.
  • Travel flexibility.
  • Financial proficiency is a plus.

 

 

#TeamMerck #NotintendedforUSorCAvisitors

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